--- title: Assess Safety & Efficacy of WC3055 in Men With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia nct_id: NCT01939184 overall_status: COMPLETED phase: PHASE2 sponsor: Warner Chilcott study_type: INTERVENTIONAL primary_condition: Benign Prostatic Hyperplasia countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01939184.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01939184" ct_last_update_post_date: 2015-06-29 last_seen_at: "2026-05-12T07:29:09.585Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Assess Safety & Efficacy of WC3055 in Men With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia **Official Title:** A Study to Assess the Safety and Efficacy of WC3055 in Men With Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH) **NCT ID:** [NCT01939184](https://clinicaltrials.gov/study/NCT01939184) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 796 - **Lead Sponsor:** Warner Chilcott - **Conditions:** Benign Prostatic Hyperplasia - **Start Date:** 2013-08 - **Completion Date:** 2014-04 - **CT.gov Last Update:** 2015-06-29 ## Brief Summary The purpose of this study is to evaluate the safety and efficacy of various fixed daily doses of WC3055 compared with placebo for the treatment of subjects with LUTS secondary to BPH. ## Eligibility - **Minimum age:** 45 Years - **Sex:** MALE - **Healthy Volunteers:** No ``` Inclusion Criteria: * History of LUTS for ≥6 months secondary to BPH * Total IPSS (International Prostate Symptom Score) ≥ 13 at Screening Exclusion Criteria: \- ``` ## Arms - **WC3055-01F** (EXPERIMENTAL) — WC3055 12.5 mg tablet once daily for 12 weeks - **WC3055-02F** (EXPERIMENTAL) — WC3055 25 mg tablet once daily for 12 weeks - **WC3055-03F** (EXPERIMENTAL) — WC3055 50 mg tablet once daily for 12 weeks - **WC3055-04F** (EXPERIMENTAL) — WC3055 75 mg tablet once daily for 12 weeks - **WC3055-07P** (PLACEBO_COMPARATOR) — Placebo tablet once daily for 12 weeks ## Interventions - **WC3055** (DRUG) — 12.5, 25, 50 or 75 mg dose - **Placebo** (OTHER) — Placebo ## Primary Outcomes - **Change from Baseline in Total IPSS (International Prostate Symptom Score)** _(time frame: Final Visit (Week 12 or final visit))_ — Sum of Questions 1-7. ## Secondary Outcomes - **Change from Baseline Total IPSS** _(time frame: Week 4)_ - **Change from Baseline Total IPSS** _(time frame: Week 8)_ - **Change from Baseline IIEF-EF (International Index of Erectile Function-Erectile Function) Domain Score** _(time frame: Week 4)_ - **Change from Baseline IIEF-EF Domain Score** _(time frame: Week 8)_ - **Change from Baseline IIEF-EF Domain Score** _(time frame: Week 12)_ - **Change from Baseline IIEF-EF Domain Score** _(time frame: Final Visit (Week 12 or Final Visit))_ ## Locations (95) - Warner Chilcott Investigational Study Site, Homewood, Alabama, United States - Warner Chilcott Investigational Study Site, Huntsville, Alabama, United States - Warner Chilcott Investigational Study Site, Mobile, Alabama, United States - Warner Chilcott Investigational Study Site, Chandler, Arizona, United States - Warner Chilcott Investigational Study Site, Gilbert, Arizona, United States - Warner Chilcott Investigational Study Site, Glendale, Arizona, United States - Warner Chilcott Investigational Study Site, Phoenix, Arizona, United States - Warner Chilcott Investigational Study Site, Laguna Hills, California, United States - Warner Chilcott Investigational Study Site, Murrieta, California, United States - Warner Chilcott Investigational Study Site, San Diego, California, United States - Warner Chilcott Investigational Study Site, San Diego, California, United States - Warner Chilcott Investigational Study Site, San Diego, California, United States - Warner Chilcott Investigational Study Site, San Diego, California, United States - Warner Chilcott Investigational Study Site, Colorado Springs, Colorado, United States - Warner Chilcott Investigational Study Site, Denver, Colorado, United States - Warner Chilcott Investigational Study Site, Denver, Colorado, United States - Warner Chilcott Investigational Study Site, Denver, Colorado, United States - Warner Chilcott Investigational Study Site, Englewood, Colorado, United States - Warner Chilcott Investigational Study Site, Parker, Colorado, United States - Warner Chilcott Investigational Study Site, Middlebury, Connecticut, United States - Warner Chilcott Investigational Study Site, New Britain, Connecticut, United States - Warner Chilcott Investigational Study Site, Aventura, Florida, United States - Warner Chilcott Investigational Study Site, Clearwater, Florida, United States - Warner Chilcottt Investigational Study Site, Clearwater, Florida, United States - Warner Chilcott Investigational Study Site, Hialeah, Florida, United States - Warner Chilcott Investigational Study Site, Jacksonville, Florida, United States - Warner Chilcott Investigational Study Site, Kissimmee, Florida, United States - Warner Chilcott Investigational Study Site, Miami, Florida, United States - Warner Chilcott Investigational Study Site, Miami, Florida, United States - Warner Chilcott Investigational Study Site, Ocala, Florida, United States - Warner Chilcott Investigational Study Site, Pembroke Pines, Florida, United States - Warner Chilcott Investigational Study Site, Tallahassee, Florida, United States - Warner Chilcott Investigational Study Site, Atlanta, Georgia, United States - Warner Chilcott Investigational Study Site, Sandy Springs, Georgia, United States - Warner Chilcott Investigational Study Site, Coeur d'Alene, Idaho, United States - Warner Chilcott Investigational Study Site, Chicago, Illinois, United States - Warner Chilcott Investigational Study Site, Evanston, Illinois, United States - Warner Chilcott Investigational Study Site, Melrose Park, Illinois, United States - Warner Chilcott Investigational Study Site, Springfield, Illinois, United States - Warner Chilcott Investigational Study Site, Springfield, Illinois, United States - Warner Chilcott Investigational Study Site, Anderson, Indiana, United States - Warner Chilcott Investigational Study Site, Fort Wayne, Indiana, United States - Warner Chilcott Investigational Study Site, Jeffersonville, Indiana, United States - Warner Chilcott Investigational Study Site, Muncie, Indiana, United States - Warner Chilcott Investigational Study Site, Newburgh, Indiana, United States - Warner Chilcott Investigational Study Site, West Des Moines, Iowa, United States - Warner Chilcott Investigational Study Site, Overland Park, Kansas, United States - Warner Chilcott Investigational Study Site, Shreveport, Louisiana, United States - Warner Chilcott Investigational Study Site, Elkridge, Maryland, United States - Warner Chilcott Investigational Study Site, Glen Burnie, Maryland, United States - Warner Chilcott Investigational Study Site, Owing Mills, Maryland, United States - Warner Chilcott Investigational Study Site, Towson, Maryland, United States - Warner Chilcott Investigational Study Site, Brookline, Massachusetts, United States - Warner Chilcott Investigational Study Site, Omaha, Nebraska, United States - Warner Chilcott Investigational Study Site, Las Vegas, Nevada, United States - Warner Chilcott Investigational Study Site, Lawrenceville, New Jersey, United States - Warner Chilcott Investigational Study Site, Albuquerque, New Mexico, United States - Warner Chilcott Investigational Study Site, Albany, New York, United States - Warner Chilcott Investigational Study Site, Brooklyn, New York, United States - Warner Chilcott Investigational Study Site, Garden City, New York, United States - Warner Chilcott Investigational Study Site, Great Neck, New York, United States - Warner Chilcott Investigational Study Site, Kingston, New York, United States - Warner Chilcott Investigational Study Site, New York, New York, United States - Warner Chilcott Investigational Study Site, Newburgh, New York, United States - Warner Chilcott Investigational Study Site, Poughkeepsie, New York, United States - Warner Chilcott Investigational Study Site, Cary, North Carolina, United States - Warner Chilcott Investigational Study Site, Charlotte, North Carolina, United States - Warner Chilcott Investigational Study Site, Concord, North Carolina, United States - Warner Chilcott Investigational Study Site, High Point, North Carolina, United States - Warner Chilcott Investigational Study Site, Raleigh, North Carolina, United States - Warner Chilcott Investigational Study Site, Raleigh, North Carolina, United States - Warner Chilcott Investigational Study Site, Salisbury, North Carolina, United States - Warner Chilcott Investigational Study Site, Wilmington, North Carolina, United States - Warner Chilcott Investigational Study Site, Winston-Salem, North Carolina, United States - Warner Chilcott Investigational Study Site, Cincinnati, Ohio, United States - Warner Chilcott Investigational Study Site, Cincinnati, Ohio, United States - Warner Chilcott Investigational Study Site, Cincinnati, Ohio, United States - Warner Chilcott Investigational Study Site, Columbus, Ohio, United States - Warner Chilcott Investigational Study Site, Columbus, Ohio, United States - Warner Chilcott Investigational Study Site, Lyndhurst, Ohio, United States - Warner Chilcott Investigational Study Site, Bala-Cynwyd, Pennsylvania, United States - Warner Chilcott Investigational Study Site, Lancaster, Pennsylvania, United States - Warner Chilcott Investigational Study Site, Reading, Pennsylvania, United States - Warner Chilcott Investigational Study Site, Warwick, Rhode Island, United States - Warner Chilcott Investigational Study Site, Charleston, South Carolina, United States - Warner Chilcott Investigational Study Site, Myrtle Beach, South Carolina, United States - Warner Chilcott Investigational Study Site, Bristol, Tennessee, United States - Warner Chilcott Investigational Study Site, Austin, Texas, United States - Warner Chilcott Investigational Study Site, Dallas, Texas, United States - Warner Chilcott Investigational Study Site, San Antonio, Texas, United States - Warner Chilcott Investigational Study Site, Salt Lake City, Utah, United States - Warner Chilcott Investigational Study Site, Virginia Beach, Virginia, United States - Warner Chilcott Investigational Study Site, Winchester, Virginia, United States - Warner Chilcott Investigational Study Site, Mountlake Terrace, Washington, United States - Warner Chilcott Investigational Study Site, Wauwatosa, Wisconsin, United States ## Recent Field Changes (last 30 days) - `locations.warner chilcott investigational study site|wauwatosa|wisconsin|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|mountlake terrace|washington|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|winchester|virginia|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|virginia beach|virginia|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|salt lake city|utah|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|san antonio|texas|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|dallas|texas|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|austin|texas|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|bristol|tennessee|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|myrtle beach|south carolina|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|charleston|south carolina|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|warwick|rhode island|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|reading|pennsylvania|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|lancaster|pennsylvania|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|bala-cynwyd|pennsylvania|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|lyndhurst|ohio|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|columbus|ohio|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|cincinnati|ohio|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|winston-salem|north carolina|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|wilmington|north carolina|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|salisbury|north carolina|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|raleigh|north carolina|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|high point|north carolina|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|concord|north carolina|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|charlotte|north carolina|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|cary|north carolina|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|poughkeepsie|new york|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|newburgh|new york|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|new york|new york|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|kingston|new york|united states` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|homewood|alabama|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|huntsville|alabama|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|mobile|alabama|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|chandler|arizona|united states` — added _(2026-05-12)_ - `locations.warner chilcott investigational study site|gilbert|arizona|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01939184.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01939184* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*